A Randomized, Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Oral LPCN 1154A in Women With Postpartum Depression

Lipocine Inc.

Summary

The purpose of this research study is to test the study drug, LPCN 1154A, as a possible treatment for postpartum depression (PPD). The trial aims to determine: * If LPCN 1154A reduces depressive symptoms in subjects with severe PPD * How well LPCN 1154A is tolerated and what side effects it may cause

Eligibility

Age range: 15–45 years
Sex: Female
Healthy volunteers: No

Detailed criteria

Key Inclusion Criteria: * Are female between 15 and 45 years of age, inclusive; * Have had a depressive episode that began no earlier than second trimester and no later than the first 4 weeks following delivery * Are \< 18 months postpartum at Screening * Hamilton Depression Rating Scale (HAM-D) 17-item score indicative of severe depression Key Exclusion Criteria: * Have a history of bipolar disorder, schizophrenia or schizoaffective disorder * Are currently experiencing active psychosis per Investigator assessment * Have a history of suicidal behavior associated with the current depressive…

Locations (16)

Lipocine Investigational Site
Tucson, Arizona
Lipocine Investigational Site
Canoga Park, California
Lipocine Investigational Site
Walnut Creek, California
Lipocine Investigational Site
Aurora, Colorado
Lipocine Investigational Site
Decatur, Georgia
Lipocine Investigational Site
Idaho Falls, Idaho

Summary

Eligibility

Interventions

Locations (16)